An open, phase I/II study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ 11PCV combined with adjuvant AS02V given as a 2-dose vaccination in adults aged 18-40 years old. - EXPLO-CRD-006
- Conditions
- Two doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine.
- Registration Number
- EUCTR2006-000442-39-BE
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
The cohort to be enrolled is 23-valent pneumococcal polysaccharide vaccine naïve adults aged between 18 and 40 years old, in good general health at the time of the first vaccine dose.
All subjects must satisfy to the following criteria at study entry:
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).
•A male or female between 18 and 40 years of age at the time of the first vaccination.
•Written informed consent obtained from the subject
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Previous vaccination against Streptococcus pneumoniae.
•Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests, at the discretion of the investigator.
•Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C or Axillary temperature <37.5°C.
•History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
•All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
•Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine.
•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
•Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
•History of administration of an experimental/licensed vaccine containing MPL or QS21.
•History of chronic alcohol consumption and/or drug abuse.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method